Multiple Ascending Dose Study of AMG 598 in Adults With Obesity

Amgen

Status and phase: Completed; Phase 1

Conditions: Obesity

Treatments: Drug: Placebo; Drug: AMG 598; Drug: Liraglutide

Study type: Interventional

Funder types: Industry

Identifiers

NCT03757130

20170139

Details and patient eligibility

About

The main objective of this study is to assess the safety and tolerability of multiple doses of AMG 598 administered alone or in combination with liraglutide in adults with obesity.

Enrollment: 50 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Men and women with ages between 18 and 65 years old, inclusive, at time of signing consent
• Body mass index (BMI) between greater than or equal to 30.0 kg/m^2 and less than or equal to 40.0 kg/m^2 at screening
• Except for obesity, otherwise healthy or medically stable per protocol
• Have a stable body weight defined as less than 5 kg self-reported change during the previous 8 weeks prior to screening
• Other Inclusion criteria may apply
• Stable on liraglutide, depending on cohort

Exclusion criteria

• History or clinical evidence of diabetes
• Inadequate organ function at screening
• Currently receiving treatment in another investigational device or drug study
• Women who are pregnant/lactating/breastfeeding or who plan to become pregnant/breastfeed while on study through 5 months after receiving the last dose of investigational product
• History or evidence of a clinically significant disorder, condition or disease that would pose a risk to subject safety or interfere with the study evaluation, procedures or completion
• A family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2; a personal history of non-familial medullary thyroid carcinoma; confirmed chronic pancreatitis or idiopathic acute pancreatitis, or gallbladder disease (ie, cholelithiasis or cholecystitis) not treated with cholecystectomy, for cohorts receiving liraglutide
• History of major depressive disorder
• Other Exclusion criteria may apply

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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50 participants in 8 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for a total of 3 doses.

Treatment:

Drug: Placebo

Placebo + Liraglutide

Active Comparator group

Description:

Participants received placebo subcutaneous injection once every 4 weeks for a total of 3 doses in addition to liraglutide administered by subcutaneous injection once a day for 12 weeks. The starting dose of liraglutide was 0.6 mg/day, increasing in increments of 0.6 mg/day every 7 days to reach the full dosage of 3 mg/day by week 5.

Treatment:

Drug: Placebo

Drug: Liraglutide

AMG 598 70 mg

Experimental group

Description:

Participants received 70 mg AMG 598 by subcutaneous injection once every 4 weeks (Q4W) for a total of 3 doses.

Treatment:

Drug: AMG 598

AMG 598 70 mg + Liraglutide

Experimental group

Description:

Participants received 70 mg AMG 598 by subcutaneous injection once every 4 weeks for a total of 3 doses in addition liraglutide administered by subcutaneous injection once a day for 12 weeks. The starting dose of liraglutide was 0.6 mg/day, increasing in increments of 0.6 mg/day every 7 days to reach the full dosage of 3 mg/day by week 5.

Treatment:

Drug: AMG 598

Drug: Liraglutide

AMG 598 210 mg

Experimental group

Description:

Participants received 210 mg AMG 598 by subcutaneous injection once every 4 weeks for a total of 3 doses.

Treatment:

Drug: AMG 598

AMG 598 210 mg + Liraglutide

Experimental group

Description:

Participants received 210 mg AMG 598 by subcutaneous injection once every 4 weeks for a total of 3 doses in addition to liraglutide administered by subcutaneous injection once a day for 12 weeks. The starting dose of liraglutide was 0.6 mg/day, increasing in increments of 0.6 mg/day every 7 days to reach the full dosage of 3 mg/day by week 5.

Treatment:

Drug: AMG 598

Drug: Liraglutide

AMG 598 420 mg

Experimental group

Description:

Participants received 420 mg AMG 598 by subcutaneous injection once every 4 weeks for a total of 3 doses.

Treatment:

Drug: AMG 598

AMG 598 420 mg + Liraglutide

Experimental group

Description:

Participants received 420 mg AMG 598 by subcutaneous injection once every 4 weeks for a total of 3 doses in addition to liraglutide administered by subcutaneous injection once a day for 12 weeks. The starting dose of liraglutide was 0.6 mg/day, increasing in increments of 0.6 mg/day every 7 days to reach the full dosage of 3 mg/day by week 5.

Treatment:

Drug: AMG 598

Drug: Liraglutide